A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-02-28

Brief Summary

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A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lastacaft ®

One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2

Group Type ACTIVE_COMPARATOR

Lastacaft ®

Intervention Type DRUG

Tears Naturale ®

One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2

Group Type PLACEBO_COMPARATOR

Tears Naturale ® (Placebo)

Intervention Type DRUG

Interventions

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Lastacaft ®

Intervention Type DRUG

Tears Naturale ® (Placebo)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
* Have a positive CAC reaction at Visit 1
* Have a positive conjunctival inflammation score at Visit 1

Exclusion Criteria

* May not use disallowed medications in specified washout period
* May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
* May not have active ocular infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No